An accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate. Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium acetate buffer (adjusted to pH 2.80) (40%): acetonitrile (10%) in an isocratic mode. The drugs were detected at 270 nm with a flow rate of 1.0 ml/min, and the retention times were found to be 3.26, 5.42, and 7.55 minutes for lamivudine, nevirapine, and tenofovir disoproxil fumarate, respectively. The developed method was validated per ICH guidelines. Good linearity was obtained within the concentration ranges of 10–59 µg/ml, 7–42 µg/ml, and 15–90 µg/ml with a correlation coefficient of not less than 0.990. The % RSD values for precision (intraday and interday) and accuracy studies were found to be less than 2%. The results obtained from quantitative analysis conform to USP content requirements for marketed tablet dosage forms, RICOVIR-LN, and tenofovir disoproxil fumarate/lamivudine tablets. The method is therefore useful for routine quality control of antiretroviral tablet dosage forms containing tenofovir disoproxil fumarate, lamivudine, and nevirapine.

中文翻译：

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同时测定固定剂量复方口服抗病毒药物中拉米夫定、替诺福韦和奈韦拉平的含量的简单 RP-HPLC 方法

已开发并验证了一种准确、快速的反向 HPLC 方法，用于同时定量拉米夫定、奈韦拉平和富马酸替诺福韦二吡呋酯。在 Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) 上使用流动相、甲醇 (50%)：醋酸铵缓冲液（调节至 pH 2.80）（40%）：乙腈（10%）以等度模式实现了合适的分离. 在 270 nm 处以 1.0 ml/min 的流速检测药物，发现拉米夫定、奈韦拉平和富马酸替诺福韦二吡呋酯的保留时间分别为 3.26、5.42 和 7.55 分钟。开发的方法根据 ICH 指南进行了验证。在 10–59 µg/ml、7–42 µg/ml 和 15–90 µg/ml 的浓度范围内获得了良好的线性，相关系数不小于 0.990。发现精密度（日内和日间）和准确度研究的 % RSD 值小于 2%。定量分析结果符合美国药典对上市片剂剂型、RICOVIR-LN 和富马酸替诺福韦二吡呋酯/拉米夫定片的含量要求。因此，该方法可用于含有富马酸替诺福韦地索普西、拉米夫定和奈韦拉平的抗逆转录病毒片剂剂型的常规质量控制。